Friday, June 5; 8:30am – 11:30am
Half-Day Course

Course Description:
This half-day course provides a focused, practical update on analytical procedure validation aligned with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ICH Q2(R2) and ICH Q14. Participants will gain clarity on lifecycle-based validation, enhanced performance characteristic expectations, revised accuracy and precision concepts, and integration of risk management principles into validation design.

The program emphasizes linking analytical method development knowledge to validation strategy, establishing scientifically justified performance characteristics, and defining appropriate control strategies. Real-world regulatory expectations, common inspection findings, and documentation best practices are discussed. Attendees will leave with practical tools to implement compliant, risk-based, and inspection-ready validation approaches within modern pharmaceutical quality systems.

Learning Benefits

• Understand lifecycle approach linking development and validation activities
• Interpret updated validation characteristics under Q2(R2) requirements
• Apply risk management principles to analytical validation strategy
• Define appropriate performance characteristics based on method purpose
• Establish robustness studies aligned with enhanced regulatory expectations
• Develop validation protocols supporting inspection-ready documentation practices
• Integrate Q14 development knowledge into validation justification framework
• Address common regulatory deficiencies observed during agency inspections

About the Instructor:

Kim Huynh-Ba is the Managing Director of Pharmalytik (www.pharmalytik.com) providing consulting and training, specializing in quality systems, validation, CMC and stability sciences. She is a member of the US Pharmacopeia’s Council of Experts and the Chair of the Small Molecules Monographs 4 Expert Committee for the 2015-2025 cycle. She was a member of USP Organic Impurities Expert Panels. Kim is a member of the EAS Governing Board and their 2013 President. She is an adjunct professor at Temple University‐ RAQA Program and Illinois Institute of Technology teaching Pharmaceutical Analysis, Quality audit, ICH Quality Guidelines, and GMP. Kim authored over 80 technical publications and book chapters. She is the editor of the “Stability Handbook in Pharmaceutical Laboratories” and more recently the textbook of “Pharmaceutical Testing for the Pharmaceutical GMP Lab”.